BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL UNK

    MDR report key: 2211865 · Received August 10, 2011

    Report

    Report Number
    1644487-2011-01838
    Event Type
    Malfunction
    Date Received
    August 10, 2011
    Date of Event
    July 7, 2011
    Report Date
    July 14, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH A COMPANY REPRESENTATIVE THAT A PHYSICIAN HAD CONTACTED HIM AS HE COULD NOT INTERROGATE A PT'S GENERATOR. THE PT REPORTED STILL BEING ABLE TO FEEL A TINGLE IN HER THROAT. THE PT WAS IMPLANTED IN 2005 AND LAST SETTINGS WERE PROGRAMMED TO 1 MA. AT THE MOMENT GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE REPORTING PHYSICIAN HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL UNK LYJ CYBERONICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown